# K100081: Enteroscopy Overtube, Model 00712140

- Pathway: 510(k) (Traditional)
- Applicant: United States Endoscopy Group, Inc.
- Decided: Apr 12, 2010 after 90 days
- Product code: FED (Endoscopic Access Overtube, Gastroenterology-Urology)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K993704 (2000). 13 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040836: Disposable Overtube, United States Endoscopy Group, Inc. (2004) Summary page 1.
- K080050: Spirus Medical Endo-Ease Endoscopic Overtube, Spirus Medical, Inc. (2008) Summary page 1.
- K903842: ST-E1 Overtube, Olympus Corp. (1991) Summary page 1.
- K092221: Colonic Splinting Overtube, Model 00711145, United States Endoscopy Group, Inc. (2009) Summary page 1.

## Most influential descendants
- K110531: Endoflip Ecd (2011), 1 descendant of its own
- K192691: PatCom Single-Use Introducer (2020), 0 descendants of its own
- K150083: Sidecar External Working Channel (2015), 0 descendants of its own

## Indications for use
The Enteroscopy Overtube is indicated for use to aid the insertion, advancement and removal of appropriately sized endoscopes and endoscopic devices during diagnostic and therapeutic endoscopic procedures in the upper gastrointestinal tract, including the small intestine.

Source page: https://510kreport.com/device/K100081
Methodology: https://510kreport.com/methodology